PMA
P060017: GENESEARCH BREAST LYMPH NODE(BLN) ASSAY
FDA PMA · RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection · Janssen Diagnostics
Key facts
| PMA number | P060017 |
|---|---|
| Trade name | GENESEARCH BREAST LYMPH NODE(BLN) ASSAY |
| Generic name | RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection |
| Applicant | Janssen Diagnostics |
| Product code | OCB |
| Approval date | Jul 16, 2007 |
| Docket number | 07M-0413 |
| Notice date | Nov 9, 2007 |
| FEI number | 3004619490 |
At a glance
- 1–9 Supplements
- Dec 17, 2009 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: